This article reviews several new developments that affect the reporting of product-related injuries and product problems. Primary among these is the FDA's new emphasis on postmarket surveillance for drugs, devices, and biologicals. Secondary to the FDA's actions are changes in products liability law for medical devices and their potential effects on the liability of user facilities. Manufacturers, distributors, and user facilities must review their medical device reporting (MDR) procedures to assure they meet the current legal requirements and best serve the entity's risk management goals.
The Climate Change and Public Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster
Provide Website Feedback - https://www.lsu.edu/feedback
Accessibility Statement - https://www.lsu.edu/accessibility